PLAIN ENGLISH SUMMARY Researchers who conduct studies in health and social care are encouraged to involve the public as early as possible in the process of designing their studies. Before their studies are allowed to start researchers must seek approval from a Research Ethics Committee, which will assess whether the study is going to be safe and ethical for patients or healthy volunteers to take part in. The process of ethical review does not consider how researchers work with patients and the public early on to design their studies. Furthermore, there is no requirement for researchers to seek ethical approval for public involvement. However, in our work advising researchers about public involvement we have found that the ways in which researchers involve the public in the design of their studies are sometimes unintentionally unethical, and this is the focus of our paper. We have observed ten areas where ethical issues may arise because of the actions researchers may or may not take and which might consequently have a negative impact. Therefore, we have used these observations to develop a "framework" to help researchers and the public work together at the early design stage in ways that are ethical. Our intention for the framework is to help researchers be mindful of these ten areas and how easily ethical issues can arise. The framework suggests some ways to overcome the potential issues in each of the ten areas. The ten areas are: 1) Allocating sufficient time for public involvement; 2) Avoiding tokenism; 3) Registering research design stage public involvement work with NHS Research & Development Trust Office at earliest opportunity; 4) Communicating clearly from the outset; 5) Entitling public contributors to stop their involvement for any unstated reasons; 6) Operating fairness of opportunity; 7) Differentiating qualitative research methods and public involvement activities; 8) Working sensitively; 9) Being conscious of confidentiality and 10) Valuing, acknowledging and rewarding public involvement. We looked to see whether any other similar approaches to helping researchers address potential ethical issues when working with the public on designing studies have been published and to our knowledge none exist. Our framework is presented as a draft and believe that it would now benefit from input from researchers and the public to gauge how useful it is and whether there are any other possible situations that it might need to cover. ABSTRACT The current paper highlights real life examples of how ethical issues can arise during public involvement activities at the research design stage. We refer to "the research design stage" as the time between the generation of the research ideas and when formal permissions to start the work including ethical approval are granted. We argue that although most researchers work ethically at this early stage, some may still benefit from being informed about ethically conscious approaches to involving the public. The paper highlights 10 ethical issues that we have observed with involving the public at the research design stage. We provide examples of these observed scenarios to illustrate the issues and make suggestions for how they can be avoided to help researchers become more ethically conscious when involving the public at the research design stage. Currently the draft framework comprises: 1) Allocating sufficient time for public involvement; 2) Avoiding tokenism; 3) Registering research design stage public involvement work with NHS Research & Development Trust Office at earliest opportunity; 4) Communicating clearly from the outset; 5) Entitling public contributors to stop their involvement for any unstated reasons; 6) Operating fairness of opportunity; 7) Differentiating qualitative research methods and public involvement activities; 8) Working sensitively; 9) Being conscious of confidentiality and 10) Valuing, acknowledging and rewarding public involvement. The draft framework will help researchers to recognise the ethical issues when involving the public and is intended to be used voluntarily in a self-regulatory way. We believe that the draft framework requires further consultation and input from the wider research community and the public before endorsement by national UK bodies such as INVOLVE and the Health Research Authority (HRA).

中文翻译：

---

在NHS健康和社会护理研究的设计阶段，公众参与的框架：制定道德意识标准的时间。

普通英语摘要鼓励从事健康和社会护理研究的研究人员在设计研究过程中尽早让公众参与。在允许其研究开始之前，研究人员必须获得研究伦理委员会的批准，该委员会将评估研究是否对患者或健康志愿者参加而言是安全和符合道德的。伦理审查过程未考虑研究人员如何尽早与患者和公众合作设计研究。此外，研究人员无需寻求道德批准即可参与公众活动。但是，在为研究人员提供有关公众参与的建议中，我们发现研究人员在设计研究时让公众参与的方式有时是无意间不道德的，这是我们论文的重点。我们观察到了十个领域，这些问题可能由于研究人员可能采取或可能不采取的行动而引起道德问题，从而可能产生负面影响。因此，我们利用这些观察结果建立了一个“框架”，以帮助研究人员和公众在早期设计阶段以合乎道德的方式共同努力。我们对该框架的意图是帮助研究人员注意这十个领域，以及如何容易地出现道德问题。该框架提出了一些方法来克服这十个领域中潜在的问题。这十个领域是：1）分配足够的时间让公众参与；2）避免象征主义；3）尽早向NHS研究与发展信托办公室注册研究设计阶段的公众参与工作；4）从一开始就清晰沟通；5）鼓励公共贡献者出于任何未说明的原因停止其参与；6）机会的经营公平性；7）区分定性研究方法和公众参与活动；8）敏感地工作；9）意识到保密性，以及10）重视，认可和奖励公众参与。我们希望查看是否有其他类似的方法可以帮助研究人员在与公众合作进行研究设计时解决潜在的道德问题，并且据我们所知不存在。我们的框架以草案的形式提出，并认为它现在将受益于研究人员和公众的意见，以评估其有用性以及是否需要涵盖其他可能的情况。摘要本篇论文重点介绍了现实生活中在研究设计阶段公众参与活动中可能出现道德问题的例子。我们将“研究设计阶段”称为研究想法产生与正式开始工作（包括伦理批准）之间的时间。我们认为，尽管大多数研究人员在这个早期阶段就进行道德操守，但仍可以从了解公众参与的道德意识方法中受益。本文重点介绍了我们在研究设计阶段涉及公众的10个道德问题。我们提供了这些观察到的场景的示例，以说明问题并就如何避免这些问题提出建议，以帮助研究人员在研究设计阶段让公众参与时，更加具有道德意识。目前，该框架草案包括：1）分配足够的时间让公众参与；2）避免象征主义；3）尽早向NHS研究与发展信托办公室注册研究设计阶段的公众参与工作；4）从一开始就清晰沟通；5）鼓励公共贡献者出于任何未说明的原因停止其参与；6）机会的经营公平性；7）区分定性研究方法和公众参与活动；8）敏感地工作；9）意识到保密性，以及10）重视，认可和奖励公众参与。该框架草案将帮助研究人员在公众参与时认识到道德问题，并旨在以自律方式自愿使用。我们认为，该框架草案需要得到更广泛的研究界和公众的进一步咨询和意见，然后才能获得英国国家机构（如INVOLVE和卫生研究局（HRA））的认可。